A randomized, multicenter, placebo-controlled clinical trial of racotumomab-alum vaccine as switch maintenance therapy in advanced non-small cell lung cancer patients.

Autor:	Alfonso S; Authors' Affiliations: Celestino Hernández Robau Hospital, Villa Clara;, Valdés-Zayas A; Center of Molecular Immunology;, Santiesteban ER; José R. López Tabranes Hospital, Matanzas;, Flores YI; National Institute of Oncology and Radiobiology; and., Areces F; National Institute of Oncology and Radiobiology; and., Hernández M; Center of Molecular Immunology;, Viada CE; Center of Molecular Immunology;, Mendoza IC; National Coordinating Center of Clinical Trials., Guerra PP; National Coordinating Center of Clinical Trials., García E; National Coordinating Center of Clinical Trials., Ortiz RA; Authors' Affiliations: Celestino Hernández Robau Hospital, Villa Clara;, de la Torre AV; Authors' Affiliations: Celestino Hernández Robau Hospital, Villa Clara;, Cepeda M; Authors' Affiliations: Celestino Hernández Robau Hospital, Villa Clara;, Pérez K; Center of Molecular Immunology;, Chong E; Center of Molecular Immunology;, Hernández AM; Center of Molecular Immunology;, Toledo D; Center of Molecular Immunology;, González Z; Center of Molecular Immunology;, Mazorra Z; Center of Molecular Immunology;, Crombet T; Center of Molecular Immunology;, Pérez R; Center of Molecular Immunology;, Vázquez AM; Center of Molecular Immunology;, Macías AE; Center of Molecular Immunology; amparo@cim.sld.cu.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2014 Jul 15; Vol. 20 (14), pp. 3660-71. Date of Electronic Publication: 2014 May 01.
DOI:	10.1158/1078-0432.CCR-13-1674
Abstrakt:	Purpose: Racotumomab-alum is an anti-idiotype vaccine targeting the NeuGcGM3 tumor-associated ganglioside. This clinical trial was conducted to provide a preliminary estimate of efficacy and safety of racotumomab as switch maintenance for patients with advanced non-small cell lung cancer (NSCLC). Experimental Design: Patients with stage IIIb/IV NSCLC who have at least stable disease after first-line chemotherapy were randomized 1:1 to racotumomab-alum (5 immunizations every 2 weeks and re-immunizations every 4 weeks) or placebo. Treatment was administered beyond progressive disease, until severe performance status worsening or toxicity. At progression, only five patients per group received further anticancer therapy. The primary endpoint was overall survival (OS). Results: One-hundred and seventy-six patients were randomized to racotumomab-alum (n = 87) and placebo (n = 89). Median OS was 8.23 and 6.80 months, respectively [HR, 0.63; 95% confidence interval (CI), 0.46-0.87; P = 0.004]. Median progression-free survival (PFS) in vaccinated patients was 5.33 versus 3.90 months for placebo (HR, 0.73; 95% CI 0.53-0.99; P = 0.039). The most common adverse events in the racotumomab-alum arm were burning and pain at the injection site, bone pain, and asthenia. A high antibody response of IgM and IgG isotype against the NeuGcGM3 ganglioside was obtained. Hyperimmune sera were able to specifically recognize and kill the NeuGcGM3-expressing L1210 cell line. Patients who developed anti-NeuGcGM3 antibodies capable to bind and kill ≥30% L1210 cells showed longer median survival times. Conclusions: Switch maintenance with racotumomab-alum is an effective and a well-tolerated treatment option for patients with advanced NSCLC. (©2014 American Association for Cancer Research.)
Databáze:	MEDLINE
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